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临床试验/NCT01827423
NCT01827423已完成不适用

Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma

University Hospital Ostrava2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2000年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma

研究概览

简要总结

This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was evaluated as well.

Blood samples from patients with sinonasal IP were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative levels of SCCA were compared.

详细描述

INTRODUCTION Squamous cell carcinoma antigen (SCCA) is a protein with a strong homology to the family of protease inhibitors known as serpins. SCCAs are cytoplasmic proteins: they are found in normal squamous epithelia, and in elevated levels in the serum of patients with squamous cell carcinomas, especially in cases of uterine cervix carcinoma, lung carcinoma, and head and neck squamous cell carcinoma. SCCA is clinically useful, especially for the staging of uterine cervix carcinoma (risk of lymph node metastasis). It is also a useful marker for monitoring during follow-up and therapy, and increasing SCCA levels may predict carcinoma relapse. Recent studies have shown a close relationship between SCCA and sinonasal inverted papilloma (IP).

IP is a relatively infrequent, benign sinonasal tumour. Careful long-term follow-up after radical surgery is necessary when treating IP, owing to its malignant potential and high recurrence rate. Distinguishing between inflammatory changes and recurrence of IP can sometimes be difficult. The purpose of this study was to determine the benefit of SCCA serum level evaluation in patients with IP.

MATERIAL AND METHODS Study design This prospective study was performed in accordance with the Declaration of Helsinki, the criteria of good clinical practice, and all applicable regulatory requirements. Written informed consent was obtained from all participants before the initiation of any procedure.

Patients with IP treated at the Department of Otolaryngology, Faculty of Medicine, University of Ostrava were included in the study. At least three years of follow-up after surgery was required for inclusion of a patient in the study.

Blood samples from enrolled patients were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative SCCA levels were compared. The changes in SCCA levels during follow-up were evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least three-year follow-up following the surgical procedure
  • signed Informed Consent

排除标准

  • patient lost during follow-up
  • patients in critical condition (ASA IV)

研究组 & 干预措施

Surgical removal of sinonasal papiloma

Experimental

The study group consisted of patients following a surgical removal of sinonasal papiloma, in which the SCCA blood levels were assessed in pre-defined intervals.

干预措施: Surgical removal of sinonasal papiloma (Device)

结局指标

主要结局

Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma

时间窗: 1 week

The levels of SCCA were assessed before and after the surgical procedure.

次要结局

  • Changes in blood levels of SCCA at six months after surgical removal of sinonasal papiloma(11 years)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

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